MAUDE Adverse Event Report: TELEFLEX HUDSON CIRCUIT, HTD DUAL LIMB W/WATER TRAPS W/O; BREATHING CIRCUIT

Catalog Number 780-36

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 07/17/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that while checking the circuit set-up for future patient use; they encountered the expiratory circuit pulled off of the cup with little effort.

Manufacturer Narrative

A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.A dhr (device history record) reviewed was conducted for batch number (b)(4) and no issues or discrepancies were found related to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to our specifications.No corrective action can be established since the sample is not available to perform an investigation and determine the source of defect reported.This customer complaint can not be confirmed due to the lack of product sample to perform an investigation and determine the source of defect reported.If device sample becomes available at a later date this complaint will be re-opened.

• Brand Name: HUDSON CIRCUIT, HTD DUAL LIMB W/WATER TRAPS W/O
• Type of Device: BREATHING CIRCUIT
• Manufacturer (Section D): TELEFLEX; nuevo laredo ; MX
• Manufacturer (Section G): TELEFLEX MEDICAL; ave. industrias no.5954; parque industrial finsa; nuevo laredo, tamaulipas 8827 5; MX 88275
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 4174448
• MDR Text Key: 18033161
• Report Number: 3004365956-2014-00313
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 780-36
• Device Lot Number: 74E1400062
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/17/2014
• Initial Date FDA Received: 08/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: VENTILATOR